BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    MDR report key: 18343370 · Received December 18, 2023

    Report

    Report Number
    0001038806-2023-02459
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    December 27, 2017
    Report Date
    May 16, 2024
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868007098
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) IOSS411, (OSSEOTITE¿ CERTAIN¿ IMPLANT 4 X 11.5MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE WITH MARKINGS FROM REMOVAL. NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. MEASUREMENTS MATCH DRAWING. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2016070089. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2016070089 FOR SIMILAR EVENTS AND 1 OTHER RELEVANT COMPLAINT(S) WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : MEDICAL : ALLERGIC REACTION. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS INADEQUATE TREATMENT PLANNING AND MATERIAL SELECTION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. NO DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE REPORTED EVENT WAS NON-VERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. D4: UNIQUE IDENTIFIER (UDI) NUMBER NOT AVAILABLE. D10: CONCOMITANT MEDICAL PRODUCT AND THERAPY DATES K063341, OSSEOTITE® CERTAIN® IMPLANT 4 X 11.5MM, LOT NUMBER: 2016070089. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    ON (B)(6), 2023, UNDER ANTIBIOTIC COVERAGE, TWO IDENTICAL AND ADJACENT IMPLANTS WERE PLACED IN THE POSTERIOR JAW WITH EXCELLENT PRIMARY STABILITY. TWO DAYS AFTER THE INTERVENTION, THE PATIENT FEELS UNWELL (POSSIBLY AN ALLERGIC REACTION) AND, FOLLOWING THE ADVICE OF THE PRIMARY PHYSICIAN, DISCONTINUES ANTIBIOTIC INTAKE. AFTER A MONTH, THE PATIENT RETURNS WITH ABSCESS-LIKE SYMPTOMS, AND ONE OF THE TWO IMPLANTS IS MOBILE IN AN EXPULSION PHASE. THE DOCTOR REPORTS PAIN. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED BY PLACING ANOTHER IMPLANTS. DENTAL POSITION AFFECTED: #46.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299279 OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2016070089 00844868007098

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male DENTAL IMPLANT| DENTAL IMPLANT